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High-Dose Chemoradiotherapy With Stem Cell Support in Patients With Relapsed or Refractory Hodgkin's Disease

Phase 2
65 Years
Not Enrolling

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Trial Information

High-Dose Chemoradiotherapy With Stem Cell Support in Patients With Relapsed or Refractory Hodgkin's Disease

OBJECTIVES: I. Determine the toxicity and response to high dose chemotherapy and peripheral
blood stem cell support in patients with recurrent or refractory Hodgkin's disease. II.
Determine the maximum tolerated dose of etoposide when combined with carboplatin and
cyclophosphamide in these patients.

OUTLINE: This is a dose escalation study of etoposide. Patients undergo total nodal
radiotherapy twice a day on days -35 to -31, -28 to -24, and then radiotherapy boost once a
day on days -21 to -17. Patients then receive etoposide IV continuously and carboplatin IV
continuously on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
Autologous peripheral blood stem cells are infused on day 0. Patients who have received
prior extensive radiation (at least 2000 cGy to any site) only receive chemotherapy and
peripheral blood stem cell infusion. Cohorts of 4-8 patients receive escalating doses of
etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose at which 1 of 4 or 2 of 8 patients experience dose limiting toxicity. Patients are
followed every 1-3 months for 2 years, then every 3 months until death.

PROJECTED ACCRUAL: At least 4 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease Refractory to standard
therapy OR Relapsed following initial complete remission Measurable or evaluable disease
Hepatic involvement must be histologically proven to be considered sole area of measurable
disease If referred following successful induction therapy, measurable or evaluable
disease not required No CNS disease

PATIENT CHARACTERISTICS: Age: Physiologic 65 or under Performance status: ECOG 0-2 Life
expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal:
Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min
Cardiovascular: No active heart disease No congestive heart failure No myocardial
infarction in the past 3 months No significant arrhythmia requiring medication Ejection
fraction normal Pulmonary: No significant nonneoplastic pulmonary disease No chronic
obstructive pulmonary disease Diffusing capacity at least 50% predicted OR FEV1 and/or FVC
at least 75% predicted (unless due to Hodgkin's disease) Other: Not pregnant Negative
pregnancy test No active serious medical condition that would preclude chemotherapy HIV
negative No clinical evidence of AIDS

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Leo I. Gordon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:

NU 93H2



Start Date:

November 1993

Completion Date:

January 2007

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611